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FDA 510(k)

BIOLOG

K-Number: K895534 · 1990-03-19

ApplicantMicromedical
Decision Date1990-03-19
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOLOG is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical. It received FDA 510(k) clearance on 1990-03-19 under 510(k) number K895534. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLOG?

BIOLOG is a medical device that received FDA 510(k) clearance on 1990-03-19. The listed applicant is Micromedical. The 510(k) number is K895534.

When did BIOLOG receive FDA 510(k) clearance?

BIOLOG received FDA 510(k) clearance on 1990-03-19, under 510(k) number K895534.

Who is the listed applicant for BIOLOG?

The FDA 510(k) record lists Micromedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOLOG?

The FDA product code for BIOLOG is DRT.

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Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 42815842Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.Regulatory toxicology and pharmacology : RTP ()PMID: 42397807Borrowing from the cancer playbook: a master protocol basket trial for hard-to-heal wound therapeutics targeting shared pathobiology.Journal of wound care ()PMID: 37496031Adapting modeling and simulation credibility standards to computational systems biology.Journal of translational medicine ()PMID: 33844189New Visualization Models of Designation Pathway and Group Categorization of Device-Drug and Device-Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions.Therapeutic innovation & regulatory science ()

Other records listing Micromedical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K895535PACEVIEW

Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

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